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A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

250 patients around the world
Available in Brazil, Argentina, Mexico
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapse/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
BeiGene
16Research sites
250Patients around the world

This study is for people with

Leukemia
Chronic lymphocytic leukemia

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Confirmed diagnosis of CLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
Previously received treatment for CLL with a BTKi and BCL2i.
Measurable disease by computer tomography/magnetic resonance imaging.
Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2.
Adequate liver function.
Adequate blood clotting function.
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months.
Known central nervous system involvement.
Prior exposure to any BTK protein degraders.
Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy.
Clinically significant cardiovascular disease.

Sites

Hospital Alemán
Av. Pueyrredón 1640, CABA, Buenos Aires
Centro de Internación e Investigación Clínica FUNDALEU
J. E. Uriburu 1450, CABA, Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Av. Crámer 1180, CABA, Buenos Aires
CEPEN - CENTRO DE PESQUISA E ENSINO DE SANTA CATARINA
R. Menino Deus, 63 - Bloco A - 3º andar - Sala 306 | 4º andar - Sala 410 - Centro, Florianópolis - SC, 88020-210
Instituto Joinvilense de Hematologia e Oncologia (CEPEVILLE)
R. Alexandre Döhler, 129 - Sala 706 - Centro, Joinville - SC, 89201-260, Brazil
Hospital Sao Lucas
Rio de Janeiro, 22061-080
Complexo Hospitalar de Niterói - CHN
Tv. Lasalle, 12 - Centro, Niterói - RJ, 24020-096
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Av. República do Líbano, 611 - Ibirapuera, São Paulo - SP, 04501-000
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC
Sao Paulo, 03102002
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Bloco A1 - Av. Albert Einstein, 627 - Jardim Leonor, São Paulo - SP, 05652-900, Brazil
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